Sub-perception Neural Modulation with Patient Feedback
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Solution Overview
Problem
Conventional neural modulation systems for conditions like chronic pain often cause uncomfortable paresthesia due to the activation of large sensory dorsal column nerve fibers, which can be an adverse side-effect, and there is a need for a system that can deliver sub-perception therapy without the patient sensing the modulation field.
Innovation Solution
A system comprising electrodes and an implantable device configured to generate a sub-perception modulation field with intensities below the patient-perception threshold, controlled by a controller that adjusts the modulation field in response to patient input, and includes an external device for communication and feedback to assess therapeutic effectiveness and calibrate the modulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional neural modulation is used to treat chronic pain, then pain relief is achieved, but uncomfortable paresthesia is caused
Solution Approach 1:
The patent changes the intensity parameter of neural modulation to sub-perception levels, below the threshold at which patients perceive paresthesia. This allows pain relief to be achieved while avoiding the uncomfortable sensation associated with conventional stimulation intensities.
Solution Approach 2:
The system incorporates feedback mechanisms where patients can report pain levels and modulation effectiveness, allowing the controller to automatically adjust stimulation parameters. This ensures optimal pain relief while maintaining sub-perception intensity to avoid paresthesia.
2Object-affected harmful factors
If sub-perception modulation is delivered, then paresthesia is avoided, but therapeutic effectiveness must be carefully calibrated
Solution Approach 1:
The system uses patient feedback reports and automated sensors to monitor therapeutic effectiveness at sub-perception levels. This feedback loop enables precise calibration of modulation intensity to ensure pain relief is achieved without causing paresthesia.
Solution Approach 2:
The system performs self-calibration using automated algorithms that analyze patient responses and adjust parameters accordingly. This reduces the need for manual programming while ensuring optimal therapeutic effectiveness at sub-perception intensities.
3Ease of operation
If automated adjustment is implemented, then patient comfort is improved, but device complexity increases
Solution Approach 1:
The controller automatically adjusts modulation parameters based on pre-programmed algorithms and patient feedback without requiring manual intervention. This self-service capability simplifies patient interaction while managing the complexity through automated decision-making processes.
Solution Approach 2:
The system includes pre-programmed adjustment algorithms and safety parameters that are prepared in advance. This preliminary configuration allows the automated system to operate within safe boundaries, reducing the perceived complexity while maintaining ease of use.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system effectively delivers pain relief without causing paresthesia, allowing for patient-controlled adjustments and self-calibration, thereby improving the therapeutic efficacy and comfort of neural modulation therapy.
Implementation Method 1
The neural modulation device is configured to use at least some of the electrodes to generate a modulation field to deliver sub-perception modulation to the neural tissue
Data Source
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AI summary
An example of a system may include electrodes on at least one lead configured to be operationally positioned for use in modulating neural tissue. The neural tissue may include at least one of dorsal horn tissue, dorsal root tissue or dorsal column tissue. The system may include an implantable device including a neural modulation device and a controller. The neural modulation device may be configured to use at least some of the electrodes to generate a modulation field to deliver sub-perception modulation to the neural tissue. The sub-perception modulation may have an intensity below a patient-perception threshold. The patient-perception threshold may be a boundary below which a patient does not sense generation of the modulation field. The controller may be configured to control the neural modulation device to generate the modulation field, and automatically adjust the modulation field in response to a patient input.